A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers

NCT ID: NCT05926609

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-27

Study Completion Date

2023-12-15

Brief Summary

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The present study is a placebo- controlled, single-blind sequential study. Total of 40 males aged between ≥ 18 years and ≤35 years will be screened. Assuming screen failure and dropout rate in this study, a minimum of 30 participants should complete the study. The treatment duration for all the study participants will be 60 days.

Detailed Description

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Conditions

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Muscle Mass and Strength

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Single-blind, placebo - controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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EB-PA

One capsule to be taken after breakfast once a day for 30 days

Group Type ACTIVE_COMPARATOR

EB-PA

Intervention Type DIETARY_SUPPLEMENT

1 capsule to be taken after breakfast once a day

Placebo

One capsule to be taken after breakfast once a day for 30 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1 capsule to be taken after breakfast once a day

Interventions

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EB-PA

1 capsule to be taken after breakfast once a day

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 capsule to be taken after breakfast once a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Males aged ≥18 to ≤ 35 years with moderate physical activity levels as per International Physical Activity Questionnaire (IPAQ-SF).
* Occasionally gym goer with a history of at least 1 month of training but not participating in the resistance-type activity for ≥3 months.
* Habitual non-veg eater
* Body mass index (BMI) 22 - 29.9 kg/ m2
* Waist Circumference 94-102 cm
* Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs before the exercise lab visit.
* Fasting blood Glucose ≤ 125 mg/ dl
* Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg
* TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L

Exclusion Criteria

* Engaged in structured weight training for more than 12 months before screening.
* Presence of chronic disease
* Changes in body weight of more than 4.5 kg (10 pounds) in the past three months
* Individuals with uncontrolled hypertension
* Known cases of Type II Diabetes mellitus
* History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders
* Individuals who have any other disease or condition or are using any medication that, in the investigator's judgment would put them at unacceptable risk for participation in the study or may interfere with evaluations or non-compliance with treatment or visits
* Individuals who have been part of a clinical trial within 90 days before the screening
* Individuals who have used whey or other supplements anytime in the last 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. Kumta Solanki's Clinic

Mumbai, Maharashtra, India

Site Status NOT_YET_RECRUITING

Dr. Preeti Bawaskar's Clinic

Thāne, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. Shalini Srivastava, MBBS, MD

Role: CONTACT

02242172300

Dr. Sonali Ghosh, BAMS

Role: CONTACT

02242172300

Facility Contacts

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Dr. Kumta Solanki, BAMS, MD

Role: primary

+919820511900

Dr. Preeti Bawaskar, BAMS, MD

Role: primary

+919146680080

Other Identifiers

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EB/230201/EB-PA/MMS

Identifier Type: -

Identifier Source: org_study_id

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